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WO2006023104A1 - Procédé et appareil permettant un revêtement par injection d'un dispositif médical - Google Patents

Procédé et appareil permettant un revêtement par injection d'un dispositif médical Download PDF

Info

Publication number
WO2006023104A1
WO2006023104A1 PCT/US2005/023622 US2005023622W WO2006023104A1 WO 2006023104 A1 WO2006023104 A1 WO 2006023104A1 US 2005023622 W US2005023622 W US 2005023622W WO 2006023104 A1 WO2006023104 A1 WO 2006023104A1
Authority
WO
WIPO (PCT)
Prior art keywords
coating
medical device
coating material
injection
outlet orifice
Prior art date
Application number
PCT/US2005/023622
Other languages
English (en)
Inventor
Anastasia Panos
Wendy Naimark
Maria Palasis
Toby Freyman
Samuel J. Epstein
Original Assignee
Boston Scientific Scimed, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Boston Scientific Scimed, Inc. filed Critical Boston Scientific Scimed, Inc.
Priority to EP05788586A priority Critical patent/EP1781209A1/fr
Publication of WO2006023104A1 publication Critical patent/WO2006023104A1/fr

Links

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05C—APPARATUS FOR APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05C5/00—Apparatus in which liquid or other fluent material is projected, poured or allowed to flow on to the surface of the work
    • B05C5/02—Apparatus in which liquid or other fluent material is projected, poured or allowed to flow on to the surface of the work the liquid or other fluent material being discharged through an outlet orifice by pressure, e.g. from an outlet device in contact or almost in contact, with the work
    • B05C5/0208—Apparatus in which liquid or other fluent material is projected, poured or allowed to flow on to the surface of the work the liquid or other fluent material being discharged through an outlet orifice by pressure, e.g. from an outlet device in contact or almost in contact, with the work for applying liquid or other fluent material to separate articles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/08—Materials for coatings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/08—Materials for coatings
    • A61L31/10—Macromolecular materials
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05C—APPARATUS FOR APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05C13/00—Means for manipulating or holding work, e.g. for separate articles
    • B05C13/02—Means for manipulating or holding work, e.g. for separate articles for particular articles
    • B05C13/025—Means for manipulating or holding work, e.g. for separate articles for particular articles relatively small cylindrical objects, e.g. cans, bottles
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05D—PROCESSES FOR APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05D1/00—Processes for applying liquids or other fluent materials
    • B05D1/002—Processes for applying liquids or other fluent materials the substrate being rotated
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05D—PROCESSES FOR APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05D1/00—Processes for applying liquids or other fluent materials
    • B05D1/26—Processes for applying liquids or other fluent materials performed by applying the liquid or other fluent material from an outlet device in contact with, or almost in contact with, the surface
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05D—PROCESSES FOR APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05D1/00—Processes for applying liquids or other fluent materials
    • B05D1/30—Processes for applying liquids or other fluent materials performed by gravity only, i.e. flow coating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A61F2002/072—Encapsulated stents, e.g. wire or whole stent embedded in lining
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2420/00—Materials or methods for coatings medical devices
    • A61L2420/02—Methods for coating medical devices

Definitions

  • the present invention relates to the coating of medical devices.
  • the present invention relates to the coating of medical devices.
  • the present invention relates to an apparatus and method for applying polymer coating and therapeutic materials (e.g., DNA, proteins or viruses) on the surface of an
  • implantable medical device such as a stent.
  • implants are used for innumerable medical purposes including the reinforcement of recently re-
  • Coating medical devices also provides for the localized delivery of therapeutic agents
  • agents to target locations within the body such as to treat localized disease (e.g., heart disease) or
  • One way to achieve localized drug delivery is by coating, for example,
  • Expandable stents are tube-like medical devices that often have a mesh-like patterned structure
  • stents designed to support the inner walls of a lumen. These stents are typically positioned within a lumen.
  • stents with the inner walls of the lumen, stents have been coated with various compounds and therapeutics to enhance their effectiveness.
  • the coating on these medical devices may provide for controlled release, which includes long-term or sustained release, of a biologically active material.
  • radiopaque materials to provide beneficial surface properties.
  • medical devices are often coated with radiopaque materials to allow for fluoroscopic visualization during placement in the body.
  • Spray coatings require multiple coating steps to achieve a desired coating thickness and do not always result in a robust coating. Thus, it is inefficient. Also, conventional
  • spray coating processes are limited to low viscosity coating solutions and DNA and other therapeutic coating materials cannot be sprayed because the therapeutic may degrade when subjected to the high stress involved in spray methods.
  • coating may lead to undesirable "webbing" of coating between stent members. Webbing of coating in the areas between stent members is unlikely to be held against the vessel wall, and this
  • coating material may be lost during deployment.
  • Patent Application Serial No. 10/455315 filed June 6, 2003, entitled “Positive Displacement
  • active agents allow for the application of coating layers of high and low viscosity, and increase
  • the drug concentration delivery dose that can be applied using a design that is readily adaptable to high through-put manufacturing.
  • the present invention regards a method and apparatus for coating at least a
  • a method for applying at least a portion of a medical device in an efficient and effective manner.
  • This method includes
  • An apparatus and method in accordance with certain embodiments can handle highly viscous coatings, such as DNA coatings or other highly viscous coatings among those described below.
  • coating material along a surface of the medical device to deposit multiple layers of coating
  • injection coating devices are used to deposit a layer of coating material, simultaneously or in
  • Figure 1 is an enlarged perspective view of a system for coating medical devices
  • Figure 2 is an enlarged perspective view of a system for coating medical devices in accordance with an alternative embodiment of the present invention, applying a coating to a medical device positioned horizontally.
  • Figure 3 is an enlarged perspective view of a system for coating medical devices
  • Figure 4 is an enlarged perspective view of a system for coating medical devices
  • Figure 5 is an enlarged side view of a system for coating medical devices in
  • Figure 6 is an enlarged side view of a system for coating medical devices in
  • injection coating devices that coat a medical device positioned horizontally.
  • Figure 7 is an enlarged perspective view of a system for coating medical devices
  • Figure 7A is an enlarged perspective view of a system for coating medical devices
  • Figure 8 is an enlarged perspective view of a system for coating medical devices
  • Figure 8 A is an enlarged perspective view of a system for coating medical devices
  • Figure 9A is an enlarged perspective view of a system for coating medical devices
  • Figure 9B is an enlarged perspective view of a system for coating medical devices
  • Figure 10 is an enlarged partial side view of a system for coating medical devices
  • coating device having circumferentially spaced coating delivery ports.
  • Figure 1 IA is an enlarged bottom view taken along line 11-11 in Figure 10 of a
  • Figure 1 IB is an enlarged bottom view taken along line 11-11 in Figure 10 of a
  • Figure 1 illustrates a system for coating a medical device having an accessible
  • Coating material 30 can be a
  • the apparatus 20 in this embodiment comprises a piston type mechanical
  • dispenser having a syringe barrel 21 and a syringe plunger 22. Attached at the outlet end of the
  • syringe barrel 21 is an outlet orifice 23.
  • the syringe plunger 22 is movable longitudinally within the syringe barrel 21.
  • apparatus 20 may be a syringe, a pipette, a positive displacement deposition apparatus, or any other mechanical dispenser device known in the art.
  • micropump a pump
  • actuator a bellows
  • Outlet orifice 23 may be a nozzle, an ultrasonic
  • nozzle a syringe needle, or any dispensing orifice known in the art.
  • the medical device 40 is positioned on a holder 50.
  • medical device 40 can be, for example, a stent having a patterned external surface as shown in
  • Holder 50 secures the medical device 40.
  • the holder 50 can be, for example, a retention clip, as shown, or an inflatable balloon or mandrel, which secures the medical device by exerting a force upon the internal surface of the medical device, thereby permitting complete
  • holder devices can be designed to secure the medical device and permit access to portions of the surface of the medical device.
  • the holder 50 can mask the internal
  • the material reservoir may fluidly communicate with outlet orifice 23.
  • the reservoir may be a
  • the separate container holding fluid outside of the syringe barrel.
  • the separate reservoir may fluidly
  • the reservoir may be the syringe
  • the reservoir may
  • the coating material 30 is deposited onto a proximal end
  • the medical device 40 to be coated for example a stent as
  • FIG. 1 may have struts 44 that extend from proximal end 42 to distal end 43,
  • medical device 40 may be placed in contact with outlet orifice 23
  • the medical device 40 is small, for example a stent,
  • the holder 50 may be attached to a motor, shown schematically in Figure 1 by block 60. Holder 50 and medical device 40 are then rotated in the direction of
  • rotational speed of motor 60 a thicker or thinner layer of coating material 30 can be applied, hi addition, rotation may also minimize collection of coating material 30 at distal end 43.
  • holder 50 may be rotated in a direction opposite direction arrow A.
  • injection coating device 20 may be rotated in the direction of direction
  • the medical device 40 shown in Figure 1 may have the injection coating
  • Rotation of the injection coating device may be achieved by attaching a motor (not shown) to the injection
  • both the medical device 40 and holder 50 are
  • medical device 40 and holder 50 may be rotated in the same direction as injection
  • the medical device 40 to be coated is substantially flat or planar, like a
  • the medical device 40 can be positioned
  • the injection coating device 20 can translate relative to the medical device 40 so that it may be able to coat the accessible surface of medical device 40. Further still, movement of both the injection coating device 20 and
  • medical device 40 can be coordinated such that a uniform layer of coating material 30 can be applied.
  • medical device 40 can be masked by a variety of
  • a second coating For example, after the first coating material is applied and dried, a second coating
  • a second injection coating device (not shown) may be used.
  • Each coating material may be the same or a
  • the properties of a multi-layer coating material may be controlled by selecting the various constituent coating materials and the order of application of the individual
  • coatings to deliver therapeutic agents may have the therapeutic effect
  • a polymer binding agent may be utilized as the first
  • drying may be accomplished in a variety
  • drying can be any of ways (e.g., vacuum drying) based on the coating formulation used.
  • drying can be any of ways (e.g., vacuum drying) based on the coating formulation used.
  • drying can be any of ways (e.g., vacuum drying) based on the coating formulation used.
  • drying can be any of ways (e.g., vacuum drying) based on the coating formulation used.
  • drying can be any of ways (e.g., vacuum drying) based on the coating formulation used.
  • drying can be any of ways (e.g., vacuum drying) based on the coating formulation used.
  • heating source may be applied to the medical device.
  • drying may be achieved by cooling the coating material, for
  • Cooling the coating material can be accomplished by attaching a cooling
  • a source may be applied externally to the medical device as illustrated in Fig. 8 A.
  • hydrophobic a hydrophilic solution may be first applied to the medical device to ensure that the
  • hydrophobic subsequent coating flows and covers the medical device.
  • the medical device Alternatively, the medical
  • the device may be vibrated (see Figure 3) or rotated to permit the downward flow of the hydrophobic
  • stainless steel medical devices generally do not have a high affinity to receive the coating
  • hydrophilic coating may be applied first to the accessible surface of the hydrophobic medical device to enhance its affinity
  • a syringe as shown in Figure 1
  • any other pumping means that can apply a pressure on the coating material 30 to dispel it from the injection coating device 20.
  • collapsible bladder m a preferred embodiment, the amount of coating material being expelled
  • the coating thickness and coating flow rate can be controlled by
  • the injection coating device 20 may be made from numerous materials, including
  • the holder 50 as one example, can be
  • an inflatable balloon made with any material that is flexible and resilient. Latex, silicone,
  • polyurethane examples include styrene and isobutylene styrene, and nylon, are each examples
  • holder 50 is a piece of materials that may be used in manufacturing the inflatable balloon.
  • holder 50 is a piece of materials that may be used in manufacturing the inflatable balloon.
  • a stainless steel clip as shown in Figures 1 and 2
  • the medical device 40 is positioned horizontally with proximal end 42 and the highest part 45 of
  • orifice 23 is smaller than the length of the medical device 40 to be coated.
  • coating material 30 is ejected from outlet orifice 23 onto accessible surface
  • Coating material 30 gravitationally flows circumferentially around medical device 40 in a downward direction along the interconnected struts 44 from the highest part 45 to the lowest part 46 of the surface to be coated.
  • Injection coating device 20 translates in the direction of direction arrow C from proximal end 42 towards
  • the medical device 40 to be coated the medical device 40 is positioned horizontally under and
  • holder 50 and medical device 40 may be rotated, e.g.,
  • Rotation may be achieved by attaching a motor (not shown) to holder 50. Rotating the holder
  • rotational speed of the motor can be controlled to allow a metered, uniform layer thickness of
  • holder 50 and medical device 40 can also be rotated in a direction opposite direction arrow D.
  • a mandrel 111 is used to secure medical device 40 and vertically position it adjacent the outlet orifice 23 of injection coating head 20 to receive the deposited coating material.
  • the mandrel 111 can secure the medical device 40 by exerting a force upon the internal surface of the medical device. This may mask the interior surface of the medical device 40 and minimize coating of the interior.
  • Mandrel 111 may extend beyond proximal end 42 of medical device 40, as shown in
  • interior lumen space of the medical device 40 forces the coating material 30 to adhere to the
  • Preferential coating may be further optimized
  • the collar onto proximal end 42 of the medical device 40.
  • the collar may also be used to mask
  • the tip of the injection coating device 20 may be placed against mandrel 111
  • Mandrel 111 may be a metal alloy or PTFE coated alloy. A skilled artisan may
  • bio-compatible materials such as stainless steel, may be utilized.
  • mandrel may be made of a porous material that can absorb coating material to
  • a suction source such as a vacuum, may be used in connection with the mandrel to avoid coating material deposition on the mandrel outer surface.
  • the inner radii of the serpentine struts of certain medical devices may be masked by
  • a vibrating device shown schematically as block 112 in Figure 3, can be attached
  • Vibrating device 112 may also shear coating material beading along medical device 40.
  • Vibrating device 112 may also shear coating material beading along medical device 40.
  • vibrating device may also be attached to holder 50 in Figures 1 and 2.
  • Mandrel 111 may also be rotated in the direction of
  • injection coating device 20 may
  • 113 in Figure 3 may be attached to the injection coating device to assist in controlling the flow
  • Vibration may enhance control of coating material
  • Vibrating the orifice can permit the dispensing of thicker or higher viscous coating materials.
  • the medical device 40 and mandrel 111 may be positioned horizontally with proximal end 42 adjacent outlet orifice 23 of injection coating device 20.
  • coating material is ejected from
  • Mandrel 111 secures medical device 40 by applying a force to the interior surface of
  • Injection coating device 20 translates in
  • mandrel 111 and medical device 40 may be rotated at a constant
  • Rotation may be achieved by attaching a motor
  • mandrel 111 (not shown) to mandrel 111.
  • the rotational speed of the mandrel can be controlled to allow a
  • the medical device 131 may have a series of interconnected large struts 132 and small struts 133.
  • Medical device 131 may be positioned vertically with a plurality of injection coating devices, shown generally as 134, positioned adjacent each series of large struts 132. m use, medical device 131 may be rotated in the direction of direction arrow A in Figure 5. Coating material may then be ejected from each outlet orifice of injection coating devices 134 onto medical device
  • the medical device 131 may be positioned horizontally with a plurality of injection coating
  • medical device 131 may
  • Coating material may then be ejected from each outlet orifice of injection coating devices 134 onto medical device 131 at the large
  • the coating material gravitationally flows circumferentially downward along the
  • additional injection coating devices 134 may be
  • a heating source schematically shown as block 151, may be attached to mandrel 111 to dry the
  • a heating source may be attached to medical device 40.
  • a heating source may be attached to a reservoir, barrel, or container
  • heat may be taken so as not to heat the biologically active agent above its degradation temperature.
  • Heat may be applied from heating source 151 or 152 to medical device 40 to
  • Heat may also facilitate drying or phase transition gelation (to facilitate release patterns
  • a cooling source may be attached to mandrel 111 to cool the
  • a cooling source may be
  • a cooling source may be directly attached to a reservoir, barrel, or container holding the coating material.
  • an external cooling source shown as 162 may be used to
  • Cooling medical device 40 may facilitate drying, for example flash
  • Cooling may also facilitate phase transition polymerization/gelation of the coating material.
  • a variety of cooling sources for example a freezing probe, can be utilized to cool the medical
  • the medical device 40 may be positioned vertically and secured by mandrel 111. Medical device 40 and mandrel 111 are positioned adjacent outlet orifice 23 of injection coating device 20.
  • Medical device 40 may be positioned on mandrel 111 such that the mandrel extends beyond the
  • medical device 40 and mandrel 111 may be translated upward in the
  • Mandrel 111 may then be inserted into outlet orifice 23 of injection coating device 20, as illustrated in Figure 9B.
  • the inner diameter of the outlet orifice 23 will be
  • mandrel 111 may be inserted into outlet orifice 23 at a length sufficient to allow even, uniform flow (e.g., an insertion depth of 5 mm).
  • Coating material 30 may then be ejected from the outlet orifice 23.
  • the coating material 30 gravitationally flows downward around mandrel 111 and onto proximal end 42 of medical device 40. By depositing coating material 30 evenly
  • Coating material 30 continues flowing longitudinally down medical device 40 from proximal end 42 towards distal end 43 along the interconnected struts.
  • the inner diameter of the outlet orifice 23 may also be slightly larger than the
  • the medical device 40 may be positioned
  • injection coating device 180 as generally shown in
  • Figures 10 may be designed with a plurality of delivery ports 181 circumferentially spaced
  • Injection coating device 180 may resemble, for example, a shower
  • This injection coating device 180 may be used in conjunction with any of the embodiments 10, 110, or 170 in Figures 1, 3, 9A, and 9B, to direct flow of coating material 30
  • Apparatus 180 may be used with pressure augmentation
  • Apparatus 180 may be used for coating/embedding stent grafts
  • FIG. 1 IB Another embodiment of the present invention, shown in Figure 1 IB, may include
  • an injection coating device 190 incorporating a circulating or rotating coating delivery port 191.
  • At least one delivery port 191 may be rotated in the direction of direction arrow F to circumferentially direct the flow of coating material 30 onto the proximal end 42 of the medical device 40.
  • the injection coating device may have multiple delivery ports arranged in a linear direction (not shown) to facilitate simultaneous or staged coating of several series of struts of a medical device. Such an arrangement may be used in conjunction with any of the embodiments
  • a conveyor system (not shown) may be provided to
  • multiple medical devices could be placed into a holder, for example a round
  • the medical devices used in conjunction with the present invention include any one of
  • the medical device may be constructed of any biocompatible material known in the arts, for example nickel or stainless
  • the medical device, or portion of the medical device, to be coated or surface modified may
  • Non-limiting examples of medical devices according to the present invention include any devices which are used, at least in part, to penetrate the body of a patient.
  • Non-limiting examples of medical devices according to the present invention include any devices which are used, at least in part, to penetrate the body of a patient.
  • Non-limiting examples of medical devices according to the present invention include any devices which are used, at least in part, to penetrate the body of a patient.
  • present invention include catheters, guide wires, balloons, filters (e.g., vena cava filters), stents, stent grafts, vascular grafts, intraluminal paving systems, soft tissue and hard tissue implants,
  • TMR myocardial revascularization
  • PMR hypodermic needles
  • soft tissue clips soft tissue clips
  • holding devices and other types
  • Such medical devices may be implanted or otherwise utilized in body lumina and organs such as the coronary vasculature, esophagus, trachea, colon, biliary tract, urinary tract,
  • prostate brain, lung, liver, heart, skeletal muscle, kidney, bladder, intestines, stomach, pancreas,
  • the coating materials used in conjunction with the present invention are any materials used in conjunction with the present invention.
  • the coating materials comprise therapeutic
  • therapeutic agents are at least partially soluble or dispersible or emulsified, and/or in combination with polymeric materials as solutions, dispersions, suspensions, latices, etc.
  • the solvents may be aqueous or non-aqueous. Coating materials with solvents may be dried or cured, with or without added external heat, after being deposited on the medical device to remove the solvent.
  • therapeutic agent may be any pharmaceutically acceptable agent such as a non-genetic
  • the coating on the medical devices may provide for controlled release, which includes long-term or sustained release, of a
  • non-genetic therapeutic agents include anti-thrombogenic agents such as
  • heparin as heparin, heparin derivatives, prostaglandin (including micellar prostaglandin El), urokinase,
  • anti-inflammatory agents such as dexamethasone, rosiglitazone, prednisolone, corticosterone, budesonide, estrogen, estradiol, sulfasalazine, acetylsalicylic acid, mycophenolic acid, and
  • anti-neoplastic/anti-proliferative/anti-mitotic agents such as paclitaxel, epothilone,
  • cladribine 5-fluorouracil, methotrexate, doxorubicin, daunorubicin, cyclosporine, cisplatin,
  • cancer agents such as antisense inhibitors of c-myc oncogene; anti-microbial agents such as
  • biof ⁇ lm synthesis inhibitors such as non-steroidal anti-inflammatory agents and chelating agents such as ethylenediaminetetraacetic acid, O,O'-bis (2-aminoethyl)ethyleneglycol-N,N,N',N'- tetraacetic acid and mixtures thereof; antibiotics such as gentamycin, rifampin, minocyclin, and ciprofolxacin; antibodies including chimeric antibodies and antibody fragments; anesthetic
  • agents such as lidocaine, bupivacaine, and ropivacaine; nitric oxide; nitric oxide (NO) donors
  • anti-coagulants such as D-Phe-Pro-Arg chloromethyl ketone, an RGD peptide- containing compound, heparin, antithrombin compounds, platelet receptor antagonists, anti-
  • thrombin antibodies anti-platelet receptor antibodies
  • enoxaparin hirudin
  • warfarin sodium enoxaparin sodium
  • tick antiplatelet factors such as tick antiplatelet factors; vascular cell growth promotors such as growth factors, transcriptional
  • vascular cell growth inhibitors such as growth factor
  • inhibitors growth factor receptor antagonists, transcriptional repressors, translational repressors,
  • bifunctional molecules consisting of a growth factor and a cytotoxin
  • bifunctional molecules consisting of an antibody and a cytotoxin
  • cholesterol-lowering agents bifunctional molecules consisting of an antibody and a cytotoxin
  • vasodilating agents bifunctional molecules consisting of an antibody and a cytotoxin
  • proteins such as geldanamycin; and any combinations and prodrugs of the above.
  • biomolecules include peptides, polypeptides and proteins
  • oligonucleotides such as double or single stranded DNA (including naked and
  • RNA Ribonucleic acids
  • antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), and ribozymes
  • genes carbohydrates; angiogenic factors including growth factors; cell cycle inhibitors; and anti-restenosis agents.
  • Nucleic acids may be incorporated into delivery
  • vectors including viral vectors
  • plasmids or liposomes.
  • Non-limiting examples of proteins include monocyte chemoattractant proteins
  • MCP-I bone morphogenic proteins
  • BMP's bone morphogenic proteins
  • Preferred BMPS are any of BMP-2, BMP-3, BMP-4, BMP-5,
  • BMP-6 BMP-6
  • BMP-7 BMP-7
  • molecules capable of inducing an upstream or downstream effect of a BMP can be provided.
  • Such molecules include any of the "hedghog” proteins, or the DNA's encoding them.
  • genes include survival genes that protect against cell death, such as anti-
  • Non-limiting examples apoptotic Bcl-2 family factors and Akt kinase and combinations thereof.
  • Non-limiting examples apoptotic Bcl-2 family factors and Akt kinase and combinations thereof.
  • angiogenic factors include acidic and basic fibroblast growth factors, vascular endothelial growth factors, vascular endothelial growth factors, and vascular endothelial growth factors.
  • hepatocyte growth factor epidermal growth factor, transforming growth factor ⁇ and ⁇ , platelet-derived endothelial growth factor, platelet-derived growth factor, tumor necrosis factor ⁇ , hepatocyte
  • a non-limiting example of a cell cycle inhibitor is
  • Non-limiting examples of anti-restenosis agents include pl5, pl6,
  • TK thymidine kinase
  • Exemplary small molecules include hormones, nucleotides, amino acids, sugars,
  • lipids and compounds have a molecular weight of less than 10OkD.
  • Exemplary cells include stem cells, progenitor cells, endothelial cells, adult
  • cardiomyocytes and smooth muscle cells.
  • Cells can be of human origin (autologous or allogenic) or from an animal source (xenogenic), or genetically engineered.
  • the polymers of the polymeric coatings may be biodegradable or non-biodegradable.
  • Non-limiting examples of suitable non-biodegradable polymers include polyvinylpyrrolidone
  • polyethylene terephthalate polyamides; polyacrylamides; polyethers including polyether sulfone; polyalkylenes including polypropylene, polyethylene and high molecular weight polyethylene;
  • polyurethanes polycarbonates, silicones; siloxane polymers; cellulosic polymers such as cellulose acetate; polymer dispersions such as polyurethane dispersions (BAYHDROL®);
  • biodegradable polymers include polycarboxylic acids
  • polyanhydrides including maleic anhydride polymers; polyisobutylene copolymers and
  • styrene-isobutylene-styrene block copolymers such as styrene-isobutylene-styrene tert-block copolymers (SIBS); polyorthoesters; poly-amino acids; polyethylene oxide; polyphosphazenes;
  • polylactic acid polyglycolic acid and copolymers and mixtures thereof such as poly(L- lactic acid) (PLLA), poly(D,L,-lactide), poly(lactic acid-co-glycolic acid), 50/50 (DL-lactide-co-PLLA)
  • PLLA poly(L- lactic acid)
  • D,L,-lactide poly(D,L,-lactide)
  • poly(lactic acid-co-glycolic acid) poly(L-co-glycolic acid)
  • 50/50 DL-lactide-co-
  • glycolide polydioxanone; polypropylene fumarate; polydepsipeptides; polycaprolactone and co ⁇ polymers and mixtures thereof such as poly(D,L-lactide-co-caprolactone) and polycaprolactone co-butylacrylate; polyhydroxybutyrate valerate and blends; polycarbonates such as tyrosine-
  • polysaccharides including hyaluronic acid; cellulose, and hydroxypropylmethyl cellulose; gelatin; starches; dextrans; alginates and derivatives thereof), proteins and polypeptides; and
  • the biodegradable polymer may also be a
  • surface erodable polymer such as polyhydroxybutyrate and its copolymers, polycaprolactone,
  • the polymer is polyacrylic acid available as
  • the polymer is a co-polymer of polylactic acid and polycaprolactone.
  • Such coatings used with the present invention may be formed by any method
  • an initial polymer/solvent mixture can be formed and then the therapeutic agent added to the polymer/solvent mixture.
  • the mixture may be a dispersion, suspension or a solution.
  • the therapeutic agent may also be mixed with the polymer in the absence of a solvent.
  • the therapeutic agent may be dissolved in the polymer/solvent mixture or in the polymer to be in a true solution with the mixture or polymer, dispersed into fine or micronized particles in the mixture or polymer, suspended in the mixture or
  • the coating may comprise multiple polymers and/or multiple therapeutic agents.
  • the release rate of drugs from drug matrix layers is largely controlled, for
  • apparatuses of the present invention may allow for a controlled release rate of a coating substance with the controlled release rate including both long-term and/or sustained release.
  • the coatings of the present invention are applied such that they result in a suitable
  • the coating is typically from about 1 to about 50 microns thick. In the case of balloon catheters,
  • the thickness is preferably from about 1 to about 10 microns, and more preferably from about 2 to about 5 microns. Very thin polymer coatings, such as about 0.2-0.3 microns and much thicker
  • coatings such as more than 10 microns, are also possible. It is also within the scope of the
  • present invention to apply multiple layers of polymer coatings onto the medical device.
  • multiple layers may contain the same or different therapeutic agents and/or the same or different polymers, which may perform identical or different functions.
  • Methods of choosing the type, thickness and other properties of the polymer and/or therapeutic agent to create different release kinetics are well known to one in the art.
  • the medical device may also contain a radio-opacifying agent within its structure
  • radio-opacifying agents are bismuth subcarbonate, bismuth
  • the coating layer or layers maybe applied for any of the following additional
  • contact angle, hardness, or barrier properties to improve corrosion, humidity and/or moisture

Landscapes

  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Surgery (AREA)
  • Vascular Medicine (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Application Of Or Painting With Fluid Materials (AREA)
  • Materials For Medical Uses (AREA)

Abstract

Il est présenté des procédés et un appareil permettant de déposer un revêtement sur au moins une partie de la surface de dispositifs médicaux (40, 131) en utilisant un dispositif de revêtement par injection (20). Dans un mode de réalisation, l'invention comprend un procédé de revêtement selon lequel un orifice (23) du dispositif de revêtement par injection (20) est placé à côté d'un dispositif médical positionné verticalement (40), un matériau de revêtement est éjecté depuis l'orifice (23) jusque sur le dispositif médical (40) et le matériau de revêtement coule par gravité vers le bas en recouvrant le dispositif médical (40). Dans un autre mode de réalisation, un orifice (23) d'un dispositif de revêtement par injection est positionné à côté d'un dispositif médical positionné horizontalement (40) de façon à couler par gravité et à déposer un matériau de revêtement sur le dispositif médical (40). Ces procédés peuvent être utilisés pour appliquer un ou plusieurs matériau(x) de revêtement simultanément ou séquentiellement. Dans un autre mode de réalisation, de multiples dispositifs de revêtement par injection (134) peuvent être utilisés. Dans certains modes de réalisation de l'invention, les matériaux de revêtement comprennent des agents thérapeutiques ou biologiquement actifs.
PCT/US2005/023622 2004-08-03 2005-07-01 Procédé et appareil permettant un revêtement par injection d'un dispositif médical WO2006023104A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP05788586A EP1781209A1 (fr) 2004-08-03 2005-07-01 Procédé et appareil permettant un revêtement par injection d'un dispositif médical

Applications Claiming Priority (2)

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US10/909,408 2004-08-03
US10/909,408 US20060029720A1 (en) 2004-08-03 2004-08-03 Methods and apparatus for injection coating a medical device

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